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Hatch-Waxman “Safe Harbor” Could Face Two-Front Battle In Supreme Court

This article was originally published in The Pink Sheet Daily

Executive Summary

Momenta plans to seek high court review of the scope of the “Bolar Amendment” in an enoxaparin patent dispute; activity in a second “safe harbor” case at the Supreme Court is expected to resume now that the appeals court proceedings in Momenta v. Amphastar have concluded.

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Hatch-Waxman “Safe Harbor” Ruling Threatens Compound Patents, Momenta Says

Enoxaparin marketing partners Momenta and Sandoz seek rehearing en banc of an appellate panel’s decision that broadly interpreted the scope of the so-called “Bolar Amendment.” Amphastar and Watson, whom the panel said were protected from patent infringement claims, oppose the request.

Manufacturing Patents In Peril After Court Extends Hatch-Waxman “Safe Harbor”

In a dispute related to Amphastar/Watson’s generic enoxaparin, a Federal Circuit panel takes an expansive view of the “Bolar Amendment” and finds that certain post-approval activities are protected from infringement claims, including quality control batch testing of commercial product. The decision draws a blistering dissent from the appeals court’s chief judge, who warns the ruling will “render manufacturing method patents worthless.”

Hatch-Waxman Safe Harbor Could Get Supreme Court Review

High court invites the Solicitor General to submit a brief after GlaxoSmithKline seeks review of a Federal Circuit finding that the safe harbor provision barring infringement claims only pertains to actions to obtain generic approvals; the ruling held GSK’s participation in a study on immunization schedules infringed Classen patents.

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